BRIDGE Device for Post-operative Pain Control (BRIDGE)

Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation

Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. The investigators propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. The investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.

Study Overview

• Status: Terminated
• Conditions: Liver Diseases; Liver Failure; Pain, Postoperative; Liver Diseases, Alcoholic; Liver Cirrhosis, Biliary; Transplant; Failure, Liver
• Intervention / Treatment: Device: BRIDGE device

Detailed Description

This is a prospective, randomized study to determine the efficacy of the BRIDGE device in reducing pain and opioid use in patients following liver transplantation. Subjects will be randomized in a 1:1 ration to one of the below groups:

Group 1: BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia

Group 2: Subjects will receive the standard of care pain control analgesia

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion criteria:

  • ≥18 years of age but <70 years of age
  • Actively listed for isolated liver transplantation
  • Subject or legally authorized representative able to sign informed consent
  • Not currently treated with opioids or any medications that may interact with opioids
  • English speaking
  • Willing and able to participate and consent to this study

Exclusion Criteria:

• Diagnosis of acute liver failure or primary sclerosing cholangitis (PSC)
• Anticipated that the subject will require a new roux-en-y hepaticojejunostomy
• Current use of opioid use or other substance abuse.
• Chronic pain disorders
• Need for regional anesthesia (regional nerve blocks or epidurals)
• Adhesive allergy/sensitivity
• Subject admitted to the ICU at the time of transplant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia	Device: BRIDGE device; an externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect
No Intervention: Group 2; Subjects will receive the standard of care pain control analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)	Comparison between study groups (BRIDGE device vs. Standard of Care)	up to day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level	Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery. The Numeric Pain Rating Scale (NPRS) ranges from 0-10, and higher scores indicate greater pain.	up to day 30
Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response	Determination of the intensity of nausea in the two groups (SOC and with device). Clinically important PONV is defined as a total score ≥50 at any time throughout the study period. Scale is 0 to infinity.	up to day 30
Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response	Determination of the intensity of vomiting in the two groups (SOC and with device) using the Simplified Postoperative Nausea and Vomiting Impact Scale, where the choices are: No, Sometimes, Often of most of the time, and All of the time.	up to day 30
Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.	Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.	up to day 5
Incidence of Post-operative Ileus Will be Measured by Number of Participants Who Need Nasogastric Decompression for >48 Hours	Determination of the presence of an ileus in the two groups (SOC and with device)	up to 48 hours
Number of Participants Who Reported Post-operative Mobility Issues as Measured by the Patient Symptom Surveys	Determination of mobility with in the two groups (SOC and with device)	up to 30 days
Average Length of Hospital Stay	Determination of length of hospital stay with in the two groups (SOC and with device)	up to 30 days
Time to Physical Function	Time to physical function measured by survey	24 hours after device has been removed
Incidence of Complications	Complications related to pain control after the device is removed.	24 hours after device has been removed
Number of Participants Who Were Re-hospitalized		up to 30 days

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Alicia Mavis, MD, Duke Universtity

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): April 3, 2020
• Study Completion (Actual): April 3, 2020

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Digestive System Diseases; Biliary Tract Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Bile Duct Diseases; Hepatic Insufficiency; Fibrosis; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Alcohol-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Liver Diseases; Liver Failure; Liver Cirrhosis, Biliary; Liver Diseases, Alcoholic
• Other Study ID Numbers: Pro00084620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No